(167 days)
Not Found
No
The device description focuses on mechanical and electrical components for cutting and sealing tissue under endoscopic visualization, with no mention of AI or ML algorithms for image analysis, decision support, or automated control.
No
This device is for surgical access, cutting, and sealing tissue during vessel harvesting, not for treating or diagnosing a medical condition.
No
This device is designed for surgical procedures involving tissue cutting and coagulation, specifically for vessel harvesting in minimally invasive surgery. It enables access, visual guidance, and tool manipulation for these surgical actions, but it does not diagnose medical conditions.
No
The device description clearly outlines a physical medical device with hardware components such as a cannula, lumens, a C-Ring, a harvesting tool with jaws, heating elements, and a handle with controls. It also requires a specific power supply. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for harvesting vessels during minimally invasive surgery. It focuses on cutting tissue, controlling bleeding, and blunt dissection. These are all surgical procedures performed directly on the patient's body.
- Device Description: The device description details a surgical tool with jaws, heating elements, and a cannula for endoscopic visualization. It describes mechanical actions (cutting, sealing, retraction) performed during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a surgical instrument used during a medical procedure, not a diagnostic tool used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The VASOVIEW HEMOPRO System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VASOVIEW HEMOPRO Harvesting Tool for cutting and sealing of vessel branches. The C-Ring/distal lens washer is independently controlled by a C-Ring Slider on the handle of the device that retracts the vessel and washes the distal tip of the Endoscope. The Harvesting Tool can be extended/retracted from the main cannula by inserting it into the Tool Adapter Port, and rotated independently. The Harvesting Tool has two curved Jaws. One Jaw contains the heating elements for branch cutting and sealing; the second Jaw is longer and has a serrated inner edge. Cutting and sealing of vessel branches is achieved in two steps: (1) capture of the branch between the HEMOPRO Jaws, and (2) simultaneous coagulation and ligation of the branch with the Jaws using direct current. Both steps are achieved by mechanical application of the Activation Toggle. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel harvesting, arterial bypass, blood vessels of the extremities, extraperitoneal or subcutaneous extremity and thoracic space, saphenous vein, radial artery, tissues of the chest wall.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing
Burst Pressure testing
Thermal Spread testing
Electrical Testing 60601-1
Shelf life testing
The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed VASOVIEW HemoPro Endoscopic Vessel Harvesting System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The profiles are silhouetted in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 19, 2016
MAQUET Cardiovascular, LLC Mr. Mark Dinger Sr. Regulatory Affairs Specialist 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K153194
Trade/Device Name: Vasoview Hemopro Endoscopic Vessel Harvesting System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 30, 2016 Received: March 31, 2016
Dear Mr. Dinger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153194
Device Name
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System
Indications for Use (Describe)
The VASOVIEW HEMOPRO System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and perioheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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VASOVIEW HemoPro Endoscopic Vessel Harvesting System 510(k) Summary
Prepared in accordance with 21 CFR Part 807.92
| 510(k) Number: | K153194 |
|---|---|
| Date Prepared: | 30 October 2015 |
| Device Owner: | MAQUET Cardiovascular LLC |
| 45 Barbour Pond Drive | |
| Wayne, New Jersey 07470 | |
| Contact Personnel: | |
| Title: | |
| Email: | |
| Phone: | Mr. Mark Dinger, B.S. |
| Sr. Regulatory Affairs Specialist | |
| mark.dinger@maquet.com | |
| 973-709-7691 | |
| Fax: 973-909-9954 | |
| Trade Name: | VASOVIEW HemoPro Endoscopic Vessel Harvesting |
| System | |
| Device Generic Name: | Electrosurgical cutting and coagulation device and |
| accessories | |
| Classification: | According to 21 CFR 878.4400 of the Federal Food, Drug |
| and Cosmetic Act, the device classification is Class II, | |
| Product code GEI. | |
| Predicate Device: | K052274 VASOVIEW HemoPro Endoscopic Vessel |
| Harvesting System (SE: 21 September 2005) | |
| Device Description: | The VASOVIEW HEMOPRO Endoscopic Vessel |
| Harvesting System is designed for use in conjunction with | |
| the 7 mm Endoscope. The Harvesting Cannula has four | |
| lumens which house the Endoscope, C-Ring, distal lens | |
| washer tube and VASOVIEW HEMOPRO Harvesting Tool | |
| for cutting and sealing of vessel branches. The C- | |
| Ring/distal lens washer is independently controlled by a | |
| C-Ring Slider on the handle of the device that retracts the | |
| vessel and washes the distal tip of the Endoscope. The | |
| Harvesting Tool can be extended/retracted from the main | |
| cannula by inserting it into the Tool Adapter Port, and | |
| rotated independently. The Harvesting Tool has two curved | |
| Jaws. One Jaw contains the heating elements for branch | |
| cutting and sealing; the second Jaw is longer and has a |
4
| serrated inner edge. Cutting and sealing of vessel branches is achieved in two steps: (1) capture of the branch between the HEMOPRO Jaws, and (2) simultaneous coagulation and ligation of the branch with the Jaws using direct current. Both steps are achieved by mechanical application of the Activation Toggle. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the VASOVIEW HEMOPRO Power Supply. | |
|---|---|
| Indications for Use: | The VASOVIEW HEMOPRO System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall. |
| Technological Characteristics | The Proposed HemoPro and the predicate devices have the following similarities: the same intended use,the same operating principles,incorporates the same basic design,sterilized using the same materials and processes,has same packaging. The Proposed HemoPro and the predicate devices have the following differences: A redesign of the electrical system in the HemoPro Tool from a Logic to a Power Switch system using the following internal components: Switch UMB: 5 Amps@ 125/250 VAC |
5
| | Toggle and Spring Toggle Return in the Toggle
• Assembly. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Molded handle halves with modified Pad prints.
• |
| | Pigtail adapter plug: To accommodate the electrical
• pigtail of the HemoPro tool, a new part required to
capture the pigtail with the handle halves. |
| | The differences are not considered a technological
difference and are substantially equivalent to the predicate
device. |
| Safety and
Performance: | MAQUET Cardiovascular's development process required
that the following activities be completed during the
development of the HemoPro: |
| | • Performance testing |
| | • Burst Pressure testing |
| | • Thermal Spread testing |
| | • Electrical Testing 60601-1 |
| | • Shelf life testing |
| | The results of the in-vitro tests conducted demonstrate that
the functionality and performance characteristics of the
device are comparable to the currently marketed
VASOVIEW HemoPro Endoscopic Vessel Harvesting
System. |
| | The reason for this 510(k) is to address the MDR issues
identified as self activated /remains activated and
overheating. |
| Conclusion: | Based upon the information submitted in this Traditional
510(k) premarket notification, MAQUET's VASOVIEW
HemoPro Endoscopic Vessel Harvesting System is
substantially equivalent to the currently marketed predicate
device. The VASOVIEW HemoPro Endoscopic Vessel
Harvesting System is similar to the predicate devices in the
intended use and the fundamental scientific technology of
the device. The performance and other testing established
that the VASOVIEW HemoPro Endoscopic Vessel
Harvesting System is substantially equivalent as the
predicate device. |